Efficacy and safety of novel oral anticoagulants for the treatment of cancer-associated venous thromboembolism: protocol for an umbrella review of systematic reviews and meta-analyses

IntroductionNovel oral anticoagulants (NOACs) have been used in antithrombotic therapy in patients with cancer, and their efficacy and safety have been evaluated in several meta-analyses. Although a large body of findings has accumulated to support the benefit of NOACs for the treatment and prevention of cancer-associated thromboembolism, there is no convincing evidence because of inconsistent results across studies and questionable data quality. Its efficacy and safety remain controversial, especially with regard to the risk of bleeding. Methods and analysis We will search PubMed, Embase and Web of science, Cochrane Library on 19 April 2022 (searches will be updated until complete) to identify systematic reviews, meta-analyses and pooled analyses of the efficacy and safety of NOACs for the treatment of cancer-associated venous thromboembolism. The quality of eligible systematic evaluations will be measured by A Measurement Tool to Assess Systematic Reviews. For each outcome, if a random effects model is not used, we will extract the data and estimate a 95% CI using the random effects model approach. For each random effects estimate, a 95% prediction interval is calculated. Heterogeneity between studies will be quantified using the I-2 metric. In addition, if an assessment contains at least three articles, we will reanalyse the assessment using Egger's asymmetry test to detect and visualise possible publication bias in the articles. Ethics and dissemination No formal ethical approval is required since we will use publicly available data. We will disseminate the findings of the umbrella review through publication in a peer-reviewed journal and conference presentations. PROSPERO registration number CRD42022342053.

Automated summary

This article aims to evaluate the efficacy and safety of novel oral anticoagulants (NOACs) in the treatment of cancer-associated venous thromboembolism through systematic reviews and meta-analyses. Although there is a substantial amount of research supporting the benefits of NOACs in the prevention and treatment of cancer-associated thromboembolism, inconsistent results and questionable data quality have led to controversy, especially in terms of bleeding risk. This study will analyze relevant research through literature search and quality assessment to obtain more accurate conclusions.